The law firm of Kirby McInerney LLP announces that a class action lawsuit has been filed in the U.S. District Court for the District of New Jersey on behalf of those who acquired Humanigen, Inc. (“Humanigen”) (NASDAQ: SFIX) publicly traded securities between May 28, 2021 through July 12, 2022, inclusive (the “Class Period”). Investors have until October 25, 2022 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
Humanigen, Inc. is a biopharmaceutical company focused on advancing medicines for patients with neglected and rare diseases.
On May 28, 2021, Humanigen issued a press release during pre-market hours announcing that the Company had submitted the lenzilumab emergency use authorization (“EUA”) to the FDA. The press release stated that “[t]his EUA application follows positive results from the LIVE-AIR Phase 3 clinical trial evaluating the ability of lenzilumab to improve the likelihood of survival without ventilation (SWOV) in newly hospitalized COVID-19 patients.”
On September 9, 2021, during pre-market hours, Humanigen issued a press release announcing that the FDA had rejected the lenzilumab EUA. On this news, the price of Humanigen shares declined by $7.14 per share, or approximately 47.25%, from $15.11 per share to close at $7.97 on September 9, 2021.
On July 12, 2022, during after-market hours, Humanigen disclosed that lenzilumab had failed to show statistical significance on the primary endpoint of the ACTIV-5/BET-B study. On this news, the price of Humanigen shares declined by $2.38 per share, or approximately 79.6%, from $2.99 per share to close at $0.61 on July 13, 2022.
The lawsuit alleges that throughout the Class Period, Defendants made materially false and misleading statements and/or failed to disclose that: (i) lenzilumab was less effective in treating hospitalized COVID-19 patients than Defendants had represented; (ii) as a result, the FDA was unlikely to approve the lenzilumab EUA and the ACTIV-5/BET-B study was unlikely to meet its primary endpoint; (iii) accordingly, lenzilumab’s clinical and commercial prospects were overstated; and (iv) as a result, the Company’s public statements were materially false and misleading at all relevant times.